From developing vaccines for mumps, chickenpox, hepatitis A, and even Ebola, American pharmaceutical giant Merck has always been out to lead the country on its biggest public health emergencies.
So when the company announced last year that it will join the race to develop a COVID-19 vaccine, it was a popular pick to win. Even if Merck was a late entrant, supporters argued, its reputation as the world’s second largest vaccine developer made it possible for the company to develop the best vaccine candidate — and easily manufacture it afterwards.
Last month, however, Merck lost its bid to the vaccine race, abandoning its two candidates after early clinical trials did not give back positive results. Now, aside from exploring two experimental COVID-19 drugs, the company is looking for ways on how to help other pharma companies manufacture their vaccines.
Developing a drug or a medical device can indeed be unpredictable. That has been proven by different companies from the industry, and sometimes, not in a good way. The Paragard IUD, for instance, was prone to breaking upon its removal. It caused different side effects to people such as heavy bleeding, ectopic pregnancy, organ perforation, and worse, it pushed them to do a full hysterectomy just to avoid further side effects from the pieces of the device left inside them.
These ultimately caused plaintiffs to file a Paragard lawsuit, where attorneys also accuse the manufacturer, Teva Pharmaceuticals, of knowingly manufacturing a faulty medical device.
It is not a surprise how a development of a vaccine can be unpredictable and not end in a way that the developers want it to.
Michael T. Nally, chief marketing officer at Merck, said that the company is in the middle of conversations with public health authorities, governments, as well as experts on determining the best way they can help in supplying the world with vaccines.
Merck did not disclose details on which companies or governments it is planning to work with, or the ways on how it plans to help. As one of the largest vaccine makers, however, it has factories that has advanced vaccine technologies, as well as ones that would make the manufacturing process much faster by having the products into ready-to-ship vials.
Nally’s statements sparked weeks of speculation about which groups, companies, or industry figures called for Merck’s help with their vaccine efforts, as the world demands for more vaccines in the midst of new COVID variants surfacing.
“Merck tried to make a vaccine, didn’t succeed,” said Mayor Bill de Blasio of New York. “And now they’re going to go off and do other types of drugs. Well, I disagree. I think the federal government should say, no, Merck, you’re producing the vaccines we have now because we have a massive shortage.”
Merck is now considering a broad range of options, both in the United States and globally, mindful of its next steps as it knows that whatever they choose would still take months to take into fruition, considering how complex the manufacturing process is. But Merck’s participation could prove to be more important for countries that do not have an adequate supply to inoculate their populations.
On the unpredictability of how long the vaccines will work, and the new strains of the virus that may challenge their efficacy, Nally said: “ I think there’s a broader recognition, certainly within the U.S. government, but governments around the world, that this is a bit more complicated than we had at one time thought.”
“If there’s a way that we can help think through that, and prepare the world for what we see on the horizon, that’s where we’re focused,” he added.
The unexpected twist in events left Merck without a leading role in the biggest public health crisis that the U.S. and the rest of the world have faced in a century. The spotlight is instead on one of its competitors, Pfizer, and an upstart, Moderna. Both of which developed highly effective vaccines in a considerably short period of time, with the help of a new technology called mRNA.
Merck’s early talks with the University of Oxford about a partnership to develop a vaccine fell through, and the university researchers ultimately chose AstraZeneca. Moderna also chose not to work with a bigger drugmaker for its COVID vaccine candidate, despite having a history of working with Merck for other vaccines.
Merck may have possibly been a victim of a vaccine development’s unpredictability. Even Sanofi and GlaxoSmithKline experienced a major problem when their vaccine failed to work on older adults.
Margaret McGlynn, former president of global vaccines at Merck, said that she was excited when Merck announced its commitment to make a vaccine, and that she believes that the company has what it takes to make a successful candidate. “But you can only tell what’s going to work by doing the trials.” McGlynn is now serving on the board of Novovax, another company that is developing a COVID-19 vaccine.
When the coronavirus began spreading all around the world, Merck was nowhere to be seen when other competitors were already announcing plans for a vaccine. By the time it shared details about two vaccine candidates, Pfizer and Moderna were already having early clinical trials.
Merck executives decided to pursue two other cures for COVID that they felt had major advantages over the others. One vaccine would be based on a harmless livestock virus, which helped yield Merck’s Ebola vaccine. The other one was based on an existing vaccine for measles.
According to the company, both of the experimental COVID vaccines would be tested with the use of a single dose, and they are also reportedly exploring the possibility of the vaccine that utilized the livestock virus being given orally — which will put them at a big advantage over their competitors, if both are proven to work.